GE Healthcare CARESTATION 750c A1 Anesthesia System Ventilation Defect
GE Healthcare CARESTATION 750c A1 anesthesia systems may not provide effective ventilation in Volume Control Ventilation mode. Affected units can achieve ventilation through alternative modes or manual operation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a critical medical device (anesthesia delivery system) with a functional defect that could prevent effective ventilation in a primary operating mode. The inability to deliver intended ventilation in VCV mode on an anesthesia system constitutes a significant risk of serious injury or death during surgery, meeting the Severe threshold.
Plain-English summary
GE Healthcare CARESTATION 750c A1 anesthesia systems (Model/REF 1012-9755-000) may not provide effective ventilation when operating in Volume Control Ventilation (VCV) mode. In affected systems, effective ventilation can be achieved through Pressure Control Ventilation (PCV) mode, Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, or manual ventilation.
The recall affects 74 units distributed worldwide, including across the United States and Puerto Rico, as well as numerous international locations. Affected units carry GTIN 00840682146425 and can be identified by specific serial numbers beginning with "SQT" (listed in FDA recall Z-1637-2025).
Healthcare facilities should verify that their CARESTATION 750c A1 systems are not affected by checking the serial number against the official FDA recall list. GE Medical Systems China Co., Ltd. is conducting this Class I recall.
The recalled product
- Product
- GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system.
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Hazard
- ventilation-failure
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00840682146425
- Serial Numbers: SQT23330001WA
- SQT23080006WA
- SQT23080007WA
- SQT23080008WA
- SQT23080009WA
- SQT23080010WA
- SQT23080011WA
- SQT24440011WA
- SQT23150001WA
- SQT23070001WA
- SQT23070002WA
- SQT24430006WA
- SQT23200001WA
- SQT23200002WA
- SQT23200003WA
- SQT23200004WA
- SQT23200005WA
- SQT24290003WA
- SQT24510015WA
Distribution
Distributed nationwide across the United States.
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